Injection device

ABSTRACT

An autoinjector device is provided. The autoinjector device can include an activator unit including an activation housing, an activation guard, and an activation shell such that a portion of the activation guard extends beyond a proximal end of the activation shell. The autoinjector device can include camouflage on a proximal surface to obscure a device lock hole and reduce user confusion around needle orientation.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of prior application U.S.application Ser. No. 16/067,724, having a 371(c) date of Jul. 2, 2018,now U.S. Pat. No. 11,590,284, which is a national phase application ofPCT/US2017/013222, filed Jan. 12, 2017, which claims the benefit of U.S.Appl. No. 62/277,939, filed Jan. 12, 2016, each of which is incorporatedby reference herein in its entirety.

FIELD

The invention relates generally to an activator unit for autoinjectorthat can include an activation guard to prevent activation of theautoinjector when the autoinjector is improperly oriented. The inventionalso relates to an autoinjector that can include the activator unit.

BACKGROUND

Activators are components of medical hypodermic syringes that can beoperated automatically, often for one-time use. Such a syringe, calledan autoinjector, is placed with its distal end on a region of intereston the body of a human and is then triggered by a manual action, oftenin the proximal region of the autoinjector. The terms “proximal” and“distal” refer to the perspective of the person using the autoinjector.A needle extends from the distal end of the autoinjector.

Autoinjectors often administer life-saving drugs under stressfulcircumstances, for example, during anaphylaxis resulting from anallergic reaction or after exposure to toxic materials or chemicals. Insuch a scenario, a user could inadvertently invert the autoinjectorrisking activation of the device into the user's thumb, palm or into theair instead of into intended region of interest.

SUMMARY

An autoinjector device is provided that can incorporate clearinstructions for use and visual and tactile cues to aide a user inproperly orienting the device to reduce the frequency of deviceinversion. The autoinjector device can also include an activation guardto prevent activation if the autoinjector device is improperly oriented.

In one aspect of the invention, an autoinjection device can include aninjection unit and an activator unit. The injector unit can be distal tothe activator unit. The activator unit can include an activation housingand an activation engine positioned within an interior area of theactivation housing. The activation engine can include a spring, apiston, a locking mechanism, and a retaining element. The activator unitcan also include an activation guard at least partially surrounding theactivation housing such that a portion of the activation housing ispositioned within an interior area of the activation guard. Theactivation guard can extend beyond a proximal end of the activationhousing. The activator unit can further include an activation shell atleast partially surrounding the activation guard such that a portion ofthe activation guard can be positioned within an interior area of theactivation shell. A portion of the activation guard can extend beyond aproximal end of the activation shell.

In an aspect, at least one of the activation housing, the activationguard, and the activation shell can be substantially cylindrical inshape. In an aspect, the activation guard can include a guard memberthat can extend beyond a proximal end of the activation housing.

In another aspect, the activation housing can include a radialprotrusion, and the activation guard can include a groove that can atleast partially surround the protrusion where the activation guard canrotate about the activation housing. In a further aspect, activationguard can include a radial protrusion, and the activation shell caninclude a groove surrounding the activation guard protrusion. In afurther aspect, the activation shell groove can include an axial lengthsuch that the activation shell can be configured to translate about theactivation guard. In another aspect, the axial length can range fromapproximately 2 mm to approximately 16 mm. In another aspect, theactivation shell and the activation guard can be configured such thatthere is a relative axial rotation between them.

In a further aspect, relative axial rotation between the activationshell and the activation guard can be configured such that relativeaxial rotation between them is prevented.

In another aspect, the autoinjector device can include a device lockthat can be configured to be positioned at a proximal end of theactivation shell.

In another aspect, the device lock can include at least a radial ridgealong an axial portion.

In another aspect, the activation shell can include a ridge on its outersurface.

In another aspect, the ridge can be configured to provide a user with avisual indication as to the end of the autoinjector that includes aneedle. In a further aspect, a proximal surface of the activation shellcan include a camouflage structure to camouflage a device lockprotrusion opening. In another aspect, a distal surface of theactivation guard can abut a shoulder of the activation housing.

In another aspect of the invention, an activator unit for anautoinjector can include an activation housing having an activationengine, an activation guard that can be configured about an exteriorsurface of the activation housing and that can extend beyond a proximalend of the activation housing, and an activation shell that can beconfigured about at least a portion of an exterior surface of theactivation guard and that can extend beyond a proximal end of theactivation shell. In another aspect, the activation housing can includeat least one protrusion, and the activation guard can include a groovesurrounding the at least one protrusion, such that the activation guardcan rotate about the activation housing. In a further aspect, theactivation guard can include at least one protrusion, and the activationshell can include at least one groove surrounding the at least oneactivation guard protrusion such that the activation shell can translateabout the activation guard. In another aspect, a proximal surface of theactivation shell can include a camouflage structure to camouflage adevice lock protrusion opening. In another aspect, a distal surface ofthe activation guard can abut a shoulder of the activation housing. In afurther aspect, the activation shell and activation guard can beconfigured such that relative axial rotation between them is prevented.In another aspect, the activation shell and activation guard can beconfigured such that they can rotate together.

In a further aspect of the invention, an activation guard for anautoinjection device to prevent a user from activating the autoinjectiondevice in an incorrect direction, wherein the activation guard caninclude a guard member that can extend proximally beyond an activationhousing and an activation shell, a groove configured on a portion of theguard member that can engage an activation housing projection, and aprojection that can be configured on a portion of the guard member thatcan engage an activation shell groove. In another aspect, a portion ofthe activation housing can be positioned within an interior area of theactivation guard, and a portion of the activation guard can bepositioned within an interior area of the activation shell. In anotheraspect, the guard member can abut a user in the incorrect direction, andan injection unit can abut a user in a correct direction.

In another aspect of the invention, an autoinjector can include anactivation shell and a device lock having a protrusion and can beconfigured to be positioned about a proximal end of the activationshell, where a proximal surface of the activation shell can include acamouflage structure to camouflage a device lock protrusion opening.

In another aspect of the invention, an activator unit for anautoinjector can include an activation housing including an activationguard at a proximal end of the activation housing, the activation guardcan be integrally formed with the activation housing, and an activationshell that can be configured about at least a portion of an exteriorsurface of the activation housing, where the activation guard can extendbeyond a proximal end of the activation shell.

Further features and advantages of embodiments of the invention, as wellas the structure and operation of various embodiments of the invention,are described in detail below with reference to the accompanyingdrawings. It is noted that the invention is not limited to the specificembodiments described herein. Such embodiments are presented herein forillustrative purposes only. Additional embodiments will be apparent to aperson skilled in the relevant art based on the teachings containedherein.

BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES

The accompanying drawings, which are incorporated herein and form partof the specification, illustrate embodiments of the present inventionand, together with the description, further serve to explain theprinciples of the invention and to enable a person skilled in therelevant art to make and use the invention.

Additional features and advantages of various embodiments will be setforth, in part, in the description that follows, and will, in part, beapparent from the description, or may be learned by the practice ofvarious embodiments. The objectives and other advantages of variousembodiments will be realized and attained by means of the elements andcombinations particularly pointed out in the description herein.

FIG. 1 is a perspective view of an autoinjector device according tovarious aspects of the invention.

FIG. 2 is a partial perspective view of an activator unit according tovarious aspects of the invention.

FIG. 3 is an assembly view of an activator unit according to variousaspects of the invention.

FIG. 4 is a sectional view of an activation housing and activation guardaccording to various aspects of the invention.

FIG. 5 is a sectional view of an activation shell and device lockaccording to various aspects of the invention.

FIG. 6 is a sectional view of an activation housing, activation guard,activation shell, and device lock according to various aspects of theinvention.

FIG. 7 is a sectional view of an autoinjector including a device lockaccording to various aspects of the invention.

FIG. 8 is a sectional view of the autoinjector device shown in FIG. 7with the device lock removed.

FIG. 9 is partial perspective view of an activation shell and devicelock according to various aspects of the invention.

FIGS. 10-12 are perspectives views of activator units according tovarious aspects of the invention.

FIG. 13 is a partial perspective view of an activation shell andactivation guard according to various aspects of the invention.

FIG. 14 is a front view and sectional view of an autoinjector device andactivator unit according to an alternate aspect of the invention.

FIG. 15 is a sectional view of an activation housing, activation guard,and activation shell according to an alternate aspect of the invention.

Features and advantages of the embodiments will become more apparentfrom the detailed description set forth below when taken in conjunctionwith the drawings, in which like reference characters identifycorresponding elements throughout. It is to be understood that both theforegoing general description and the following detailed description areexemplary and explanatory only, and are intended to provide anexplanation of various embodiments of the present teachings.

DETAILED DESCRIPTION

The present invention will now be described in detail with reference toembodiments thereof as illustrated in the accompanying drawings.References to “one embodiment,” “an embodiment,” “an exemplaryembodiment,” etc., indicate that the embodiment described may include aparticular feature, structure, or characteristic, but every embodimentmay not necessarily include the particular feature, structure, orcharacteristic. Moreover, such phrases are not necessarily referring tothe same embodiment. Further, when a particular feature, structure, orcharacteristic is described in connection with an embodiment, it issubmitted that it is within the knowledge of one skilled in the art toaffect such feature, structure, or characteristic in connection withother embodiments whether or not explicitly described.

An aspect of the present invention will now be described with referenceto FIGS. 1-2 and 7-8 . Medical uses for autoinjector device 10 mayinclude, for example, administering a therapeutic injection to apatient. Axial direction 30 can run down the center of autoinjectordevice 10. Radial direction 40 can extend radially outward from axialdirection 30. Circumferential direction 50 can encircle axial direction30 and be tangent to radial direction 40. In an aspect of the invention,autoinjector device 10 can be symmetrical about one or more planes (i.e.reflection symmetry) or about one or more axes (i.e. rotation symmetry),such as an axis that extends along axial direction 30.

Autoinjector device 10 can have a proximal end 12 and a distal end 14.With reference to FIG. 1 , autoinjector device 10 can include aninjection unit 100 at its distal end 14 and an activator unit 200 at itsproximal end 12. Autoinjector device 10 can include a visual indication20 as to the end of autoinjector device 10 that includes a needle, toassist a user in properly orienting autoinjector device 10.

With reference to FIGS. 1-8 , injection unit 100 can include housing106, a storage container such as cartridge 104, a needle 102, a pressurepin 105, and a film-type seal 107.

Housing 106 can take the general shape of a cylinder, a rectangularprism, a sphere, a cube, a cone, a pyramid, or combinations thereof. Inanother aspect, a cross section of housing 106 can be substantiallycircular in shape, ovular, round, or any other shape known to one ofskill in the art.

Cartridge 104 can be configured to hold one or more materials, such asliquids, gases, and/or solids. Cartridge 104 can hold a medicament, suchas a pharmaceutical composition, for later delivery to a user.

Cartridge 104 can be one of many shapes or sizes, depending on theparticular application. For example, cartridge 104 can take the shape ofa cylinder, a rectangular prism, a sphere, a cube, a cone, a pyramid, orcombinations thereof. Cartridge 104 illustrated in FIGS. 7-8 , issubstantially cylindrically shaped, and includes a single, centralchamber. Cartridge 104 can have a total volume of, for example, of fromabout 0.1 to about 50 ml. In an aspect of the invention, cartridge 104can have a total volume of, for example, 0.1 ml, 0.5 ml, 1 ml, 2 ml, 3ml, 4 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, 10 ml, 11 ml, 12 ml, 13 ml, 14ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, or 50 ml.

Cartridge 104 can be made from a variety of materials. In one aspect,cartridge 104 can be glass. In another aspect, cartridge 104 can be madefrom one or more plastics such as, for example, polyvinylchloride,polytetrafluoroethylene, polyethersulfone, polyethylene, polyurethane,polyetherimide, polycarbonate, polyetheretherketone, polysulfone,polypropulene, cyclic olefin polymer, cyclic olefin copolymer, orcombinations thereof. In an aspect, cartridge 104 can be rigid. In afurther aspect, cartridge 104 can compress under the pressure ofpressure pin 105.

Needle 102 can be used to pierce the user's skin and to delivermaterials to the user's body. Suitable needles may include standardneedles used for intradermal, subcutaneous, intramuscular, orintravenous injections, depending on the particular application.

Cartridge 104 can include a seal (not shown in the figures) at itsdistal end. In one example, when the autoinjector is activated, theneedle 102 punctures the cartridge seal so that the needle comes incontact with the cartridge 104, such that when a pressure is applied tothe cartridge 104, the medicament can flow from the cartridge 104through the needle 102 and into the user's body. In another example, theneedle 102 is pre-connected to the cartridge 104.

Cartridge 104 can include a pressure pin 105 at its proximal end. In oneexample, when the autoinjector is activated, a piston 208 can push thepressure pin 105 so that it moves into the cartridge 104 and creates apressure sufficient enough for the medicament to flow from the cartridge104 through the needle 102 and into the user's body. In another example,the piston 208 is pre-connected to the pressure pin 105.

In an aspect of the present invention, housing 106 can also include aseal-like structure, such as a film-type seal 107. In an embodiment,film-type seal 107 can be configured at the proximal end of theinjection unit 100. For example, film-type seal 107 can be configuredbetween the pressure pin 105 and the piston 208. Film-type seal 107 caninclude a design to maintain the sterility of the injection unit 100even when the activator unit 200 is connected to the injection unit 100.This can be accomplished by designing the autoinjector device 10, suchthat a gap exists between the piston 208 and the pressure pin 105.Accordingly, the film-type seal 107 can include a thickness that can beapproximately no more than the gap between the piston 208 and thepressure pin 105. For example, the film-type seal 107 can include athickness of from about 0.001 inch or less to about 5 inches or more,from about 0.01 inch to about 1 inch, from about 0.01 inch to about 0.5inch, or from about 0.01 inch to about 0.3 inch. Moreover, the film-typeseal 107 can be made of a material that breaks when the force of thepiston 208 is applied to the film-type seal 107.

Activator unit 200 can include an activator unit length 200L and theinjection unit 100 can include an injection unit length 100L. Theactivator unit length 200L can be from about 1 inch to about 10 inchesor more. For example, the activator unit length 200L can be from about0.5 to about 8 inches, such as from about 2 to about 6 inches, fromabout 3 to about 4 inches, or about 3 inches. Similarly, the injectionunit length 100L can be from about 1 inch to about 10 inches or more.For example, the injection unit length 100L can be from about 2 to about8 inches, such as from about 2 to about 6 inches, from about 2.5 toabout 4 inches, or about 3 inches. In one embodiment, the activator unitlength 200L can be substantially the same as the injection unit length100L. In another embodiment, the activator unit length 200L can beshorter than the injection unit length 100L. For example, the activatorunit length 200L can be at least 0.1 inches shorter than the injectionunit length 100L, such as about 0.1 inch, 0.2 inch, 0.3 inch, 0.4 inch,0.5 inch, 0.6 inch, 0.7 inch, 0.8 inch, 0.9 inch, 1 inch, 1.5 inches, 2inches, or 3 inches shorter than the injection unit length 100L. In yetanother embodiment of the present invention, the activator unit length200L can be at least 0.1 inches longer than the injection unit length100L, such as about 0.2 inch, 0.3 inch, 0.4 inch, 0.5 inch, 0.6 inch,0.7 inch, 0.8 inch, 0.9 inch, 1 inch, 1.5 inches, 2 inches, or 3 incheslonger than the injection unit length 100L.

The activator unit 200 can include at least an activator unit diameter200D and the injection unit 100 can include at least an injection unitdiameter 100D. Activator unit diameter 200D can be from about 0.1 inchto about 3 inches or more. For example, activator unit diameter 200D canbe from about 0.2 to about 2 inches, such as from about 0.3 to about 1.5inches, from about 0.4 to about 1.4 inches, from about 0.5 to about 1.3inches, from about 0.6 to about 1.2 inches, from about 0.7 to about 1.1inches, or from about 0.8 to about 1 inch. The injection unit diameter100D can be from about 0.1 inch to about 3 inches or more. For example,the injection unit diameter 100D can be from about 0.2 to about 2inches, such as from about 0.3 to about 1 inch, from about 0.4 to about0.8 inches, or from about 0.5 to about 0.75 inches. In one example, thedistal end of the injection unit 100 has a diameter different from itsproximal end. For example, the distal end of the injection unit 100includes a diameter of from about 0.3 inches to about 0.7 inches, suchas a diameter of 0.5 inches. In this example, the proximal end of theinjection unit 100 includes a diameter of from about 0.6 inches to about1 inch, for example, a diameter of 0.7 inch to about 0.9 inch, such as adiameter of about 0.8 inch.

In another embodiment of the present invention, the activator unitdiameter 200D can be substantially equal to the injection unit diameter100D. In another embodiment, the activator unit diameter 200D can belarger than the injection unit diameter 100D. For example, the activatorunit diameter 200D can be at least 0.01 inches larger than the injectionunit diameter 100D, such as about 0.05 inch, 0.1 inch, 0.2 inch, 0.3inch, 0.4 inches, or 0.5 inches larger than the injection unit diameter100D. In yet another embodiment, the activator unit diameter 200D can besmaller than the injection unit diameter 100D. For example, theactivator unit diameter 200D can be at least 0.01 inches smaller thanthe injection unit diameter 100D, such as about 0.05 inch, 0.1 inch, 0.2inch, 0.3 inch, 0.4 inches, or 0.5 inches smaller than the seconddiameter. The dimensions of the exterior of the autoinjector allows auser who is wearing protective clothing, such as a glove, to betterhandle and use the autoinjector 10 during an emergency situation.

The activator unit 200 can be connected to injection unit 100 by anymethod. For example, the activator unit 200 can be screwed, snapped,welded, glued, or friction fitted onto the injection unit 100. In oneaspect of the invention, a distal portion of activator unit 200 and aproximal portion of injection unit 100 can include matching threads. Inanother aspect of the invention, the distal portion of the activatorunit 200 and the proximal portion of injection unit 100 can include amatching tongue and groove.

Activator unit 200 can include an activation housing 210, an activationguard 220, an activation shell 230, an activation engine withinactivation engine housing 201, and a device lock 250.

Activation housing 210 encompasses the activation engine housing 201having the activation engine. The activation housing can take thegeneral shape of a cylinder, a rectangular prism, a sphere, a cube, acone, a pyramid, or combinations thereof. In another aspect, a crosssection of activation housing 210 can be substantially circular inshape, ovular, round, or any other shape known to one of skill in theart.

Activation housing 210 can be made from a variety of materials. In oneaspect, activation housing 210 can be made from a metal or a metalcomposition. In one aspect, the activation housing 210 can be made fromone or more plastics such as, for example, polyvinylchloride,polytetrafluoroethylene, polyethersulfone, polyethylene, polyurethane,polyetherimide, polycarbonate, polyetheretherketone, polysulfone,polypropulene, cyclic olefin polymer, cyclic olefin copolymer, orcombinations thereof.

Activation housing 210 can have an activation housing length 210L. Theactivation housing length 210L can be from about 1 inch to about 10inches or more. For example, activation housing length 210L can be fromabout 2 to about 8 inches, such as from about 2 to about 6 inches, fromabout 2 to about 4 inches, from about 2 to about 3 inches, or about 2.5inches.

Activation housing 210 can have an activation housing diameter 210D. Theactivation housing diameter 210D includes a diameter that is smallerthan the inner diameter of the activation guard 220 so that theactivation guard 220 can be positioned such that it can cover at least aportion of the activation housing 210. In one example, the activationhousing diameter 210D is from about 0.1 inch to about 3 inches or more.For example, the activation housing diameter 210D can be from about 0.2to about 2 inches, such as from about 0.3 to about 1.5 inches, fromabout 0.4 to about 1.4 inches, from about 0.5 to about 1.3 inches, fromabout 0.6 to about 1.2 inches, from about 0.7 to about 1.1 inches, orfrom about 0.8 to about 1 inch.

Activation housing 210 can include a radial protrusion 216. The radialprotrusion 216 secures the activation guard 220 and at the same timeallows the activation guard 220 to circumferentially rotate around theactivation housing 210. The radial protrusion 216 extends from an outersurface of activation housing 210 in radial direction 40 along at leasta portion of an outer surface of activation housing 210 incircumferential direction 50. In another aspect, radial protrusion 216can extend circumferentially along an entire outer surface of activationhousing 210. The radial protrusion 216 can be positioned or formed onany portion of the activation housing 210. For example, the radialprotrusion 216 can be positioned from about the distal end 214 of theactivation housing 210 to about the proximal end 212 of the activationhousing 210, such as the distal half of the activation housing 210, asshown in FIG. 3 . Radial protrusion 216 can extend from the outersurface of activation housing 210 a protrusion thickness 216T.Protrusion thickness 216T can be from about 0.01 inch to about 1 inch ormore. For example, protrusion thickness 216T can be from about 0.02 inchto 0.9 inch, from about 0.05 inch to about 0.8 inch, from about 0.1 inchto about 0.7 inch, from about 0.2 inch to about 0.6 inch, 0.3 inch toabout 0.5 inch, or about 0.4 inch.

In one aspect, activation housing 210 and radial protrusion 216 can be aunitary structure manufactured as a unitary piece of material. Inanother aspect, radial protrusion 216 can be a discrete piece ofmaterial that is joined onto activation housing 210.

Activation housing 210 can have a first protrusion length 216L₁ fromproximal end 212 to protrusion 216 in the axial direction. Firstprotrusion length 216L₁ can be from about 1 inch to about 16 inches ormore. For example, first protrusion length 216L₁ can be from about 1 toabout 8 inches, such as from about 1.5 to about 6 inches, from about 1.5to about 4 inches, from about 1.5 to about 3 inches, or about 1.8inches.

Activation housing 210 can have a second protrusion length 216L₂ fromdistal end 214 to protrusion 216 in the axial direction. Secondprotrusion length 216L₂ can be from about 0.1 inch to about 10 inches ormore. For example, second protrusion length 216L₂ can be from about 0.3to about 5 inches, such as from about 0.5 to about 1.5 inches, fromabout 0.6 to about 1 inch, from about 0.7 to about 0.9 inches, or about0.8 inches.

Activation housing 210 can include a shoulder 218 that can be positionedor formed on any portion of the activation housing 210. For example, theshoulder 218 can be positioned from about the distal end 214 of theactivation housing 210 to about the proximal end 212 of the activationhousing 210, such as the distal half of the activation housing 210. Inone example, the shoulder is positioned or formed below or distal to theradial protrusion 216, as shown in FIG. 4 . The shoulder 218 can bepositioned adjacent distal end 224 of activation guard such thatactivation guard distal surface 225 abuts the surface of shoulder 218.Shoulder 218 can extend outward from the outer surface of activationhousing 210 in radial direction 40 along at least a portion of an outersurface of activation housing 210 in circumferential direction 50. Inanother aspect, shoulder 218 can extend outward and circumferentiallyalong an entire outer surface of activation housing 210.

In one aspect, activation housing 210 and shoulder 218 can be a unitarystructure manufactured as a unitary piece of material. In anotheraspect, shoulder 218 can be a discrete piece of material that is joinedonto activation housing 210.

Shoulder 218 can have a shoulder diameter 218D. Shoulder diameter 218Dcan be from about 0.1 inch to about 2 inches or more. For example, theshoulder diameter 218D can be from about 0.2 to about 2 inches, such asfrom about 0.3 to about 1.5 inches, from about 0.4 to about 1.4 inches,from about 0.5 to about 1.3 inches, from about 0.6 to about 1.2 inches,from about 0.7 to about 1.1 inches, or from about 0.8 to about 1 inch.Shoulder diameter 218D can be larger than activation housing diameter210D. For example, shoulder diameter 218D can be at least 0.01 incheslarger than activation housing diameter 210D, such as about 0.1 to about0.2 inches larger than the activation housing diameter 210D.

Activation housing 210 can have a first shoulder length 218L₁ fromproximal end 212 to shoulder 218 in the axial direction. First shoulderlength 218L₁ can be from about 1 inch to about 10 inches or more. Forexample, first shoulder length 218L₁ can be from about 1.5 to about 6inches, such as from about 1.5 to about 3 inches, from about 1.5 toabout 2.5 inches, or about 2 inches.

Activation housing 210 can have a second shoulder length 218L₂ fromdistal end 214 to shoulder 218 in the axial direction. Second shoulderlength 218L₂ can be from about 1 inch to about 10 inches or more. Forexample, second shoulder length 218L₂ can be from about 0.1 to about 1inches, such as from about 0.2 to about 0.9 inches, from about 0.3 toabout 0.8 inches, from about 0.4 to about 0.7 inches, or about 0.5 toabout 0.6 inches.

Activator unit 200 can include an activation guard 220. Activation guard220 can take the general shape of a cylinder, a rectangular prism, asphere, a cube, a cone, a pyramid, or combinations thereof. In anotheraspect, a cross section of activation guard 220 can be substantiallycircular in shape, ovular, round, or any other shape known to one ofskill in the art. Activation guard 220 can be made from a variety ofmaterials. In one aspect, activation guard 220 can be made from one ormore plastics such as, for example, polyvinylchloride,polytetrafluoroethylene, polyethersulfone, polyethylene, polyurethane,polyetherimide, polycarbonate, polyetheretherketone, polysulfone,polypropulene, cyclic olefin polymer, cyclic olefin copolymer, orcombinations thereof.

Activation guard 220 can extend beyond a proximal end of an activationshell 230. When autoinjector device 10 is improperly oriented, e.g.,when proximal end 12 is positioned adjacent a user, activation guard 220abuts the user and prevents the activation shell 230 from contacting theuser and activating the autoinjector device 10.

Activation guard 220 can have an activation guard length 220L and ispositioned such that a portion of it extends beyond the proximal end ofthe activation housing 210 and the activation shell 230. The activationguard length 220L can be from about 1 inch to about 10 inches or more.For example, activation guard length 220L can be from about 1 to about 6inches, such as from about 2 to about 4 inches, from about 2 to about 3inches, or about 2.5 inches. In one embodiment of the present invention,the activation guard length 220L can be substantially the same as theactivation housing length 210L. In another embodiment of the presentinvention, the activation guard length 220L can be shorter than theactivation housing length 210L. For example, the activation guard length220L can be at least 0.1 inches shorter than the activation housinglength 210L, such as about 0.5 inch, 0.75 inch, 1 inch, 1.5 inches, 2inches, 2.5 inches, 3 inches, 3.5 inches, 4 inches, 4.5 inches, or 5inches shorter than the activation housing length 210L. In yet anotherembodiment of the present invention, activation guard length 220L can beat least 0.1 inches longer than the activation housing length 210L, suchas about 0.5 inch, 0.75 inch, 1 inch, 1.5 inches, 2 inches, 2.5 inches,3 inches, 3.5 inches, 4 inches, 4.5 inches, or 5 inches longer than theactivation housing length 210L.

Activation guard 220 can have an activation guard diameter 220D. Theactivation guard diameter 220D. The activation guard diameter 220D islarger than the activation housing diameter 210D so that it can slideover the activation housing 210 and smaller than an activation shelldiameter 230D. The activation housing diameter 220D can be from about0.1 inch to about 3 inches or more. For example, the activation guarddiameter 220D can be from about 0.2 to about 2 inches, such as fromabout 0.3 to about 1.5 inches, from about 0.4 to about 10 inch, fromabout 0.5 to about 0.8 inches, from about 0.6 to about 0.8 inches, fromabout 0.7 to about 0.8 inches.

Activation guard 220 can include a radial protrusion 228. The radialprotrusion 228 secures the activation shell 230 and at the same timeallows the activation shell 230 to move axially so that it can activatethe autoinjector 10. The radial protrusion 228 extends outward alongradial direction 40 along at least a portion of an outer surface ofactivation guard 220 in circumferential direction 50. In another aspect,radial protrusion 228 can extend circumferentially along an entire outersurface of activation guard 220. The radial protrusion 228 can bepositioned or formed on any portion of the activation guard 220. Forexample, the radial protrusion 228 can be positioned from about thedistal end of the activation guard 220 to about the proximal end of theactivation guard 220, such as the distal half of the activation guard220, as shown in FIGS. 4 and 6 . Radial protrusion 228 can extend fromthe outer surface of activation housing 210 a protrusion thickness 228T.Protrusion thickness 228T can be from about 0.01 inch to about 1 inch ormore. For example, protrusion thickness 228T can be from about 0.02 inchto 0.9 inch, from about 0.05 inch to about 0.2 inch, or from about 0.05inch to about 0.1 inch.

In one aspect, activation guard 220 and radial protrusion 228 can be aunitary structure manufactured as a unitary piece of material. Inanother aspect, radial protrusion 228 can be a discrete piece ofmaterial that is joined onto activation guard 220.

Activation guard 220 can have a first protrusion length 228L₁ fromproximal end 222 to protrusion 228 along the axial direction. Firstprotrusion length 228L₁ can be from about 1 inch to about 10 inches ormore. For example, first protrusion length 228L₁ can be from about 1 toabout 6 inches, such as from about 2 to about 4 inches, from about 2 toabout 3 inches, from about 2.0 to about 2.5 inches, or about 2.3 inches.

Activation guard 220 can have a second protrusion length 228L₂ fromdistal end 224 to protrusion 228 along the axial direction. Secondprotrusion length 228L₂ can be from about 0.01 inch to about 10 inchesor more. For example, second protrusion length 228L₂ can be from about0.05 to about 1 inch, such as from about 0.07 to about 0.5 inches, fromabout 0.07 to about 0.3 inches, or from about 0.08 to about 0.2 inches.

Activation guard 220 can have a groove 229 that interacts or engages theradial protrusion 216. The groove 229 extends radially into an interiorsurface of activation guard 220 along at least a portion of the interiorsurface of activation guard 220 in circumferential direction 50. Groove229 can have a depth from approximately 0.01 or less to approximately0.1 inch or more. In one aspect, groove 229 can extend circumferentiallyalong an entire interior surface of activation guard 220. In anotheraspect, groove 229 can extend along a portion of the interior surface ofthe activation guard 220.

Activation guard 220 can have a first groove length 229L₁ from proximalend 222 to groove 229 along the axial direction. First groove length229L₁ can be from about 1 inch to about 16 inches or more. For example,first groove length 229L₁ can be from about 1.5 to about 3 inches, suchas from about 1.5 to about 2.5 inches, or from about 2 to about 2.4inches.

Activation guard 220 can have a second groove length 229L₂ from distalend 224 to groove 229 along the axial direction. Second groove length229L₂ can be from about 0.1 inch to about 10 inches or more. Forexample, second groove length 229L₂ can be from about 0.5 to about 2inches, such as from about 0.6 to about 1 inch, or from about 0.7 toabout 0.9 inch.

In one aspect of the invention, activation guard 220 can include one ormore guard members 226, positioned at proximal end 222 of activationguard 220. In one aspect, activation guard 220 and guard members 226 canbe a unitary structure manufactured as a unitary piece of material. Inone aspect, the guard member 226 may be simply the proximal portion ofthe activation guard 220 that extends beyond the activation housing 210and the activation shell 230. In one example, the guard members 226include a gap 227, thus forming one or more guard members 226. The gap227 can extend along circumferential direction 50. Gap 227 can have anylength and width. For example, gap 227 can include a length of about0.25 inch. In another aspect, guard members 226 can be curved alongcircumferential direction 50 and can a have a radius of curvature. Forexample, guard members 226 can have a radius of curvature of from about0.2 to about 0.5 inch. In an alternate aspect of the invention, guardmember 226 can be straight and can be beam shaped, as shown, forexample, in FIGS. 15-16 . In another aspect, guard members 226 can bediscrete pieces of material that are joined onto activation guard 220.In another aspect of the invention, one or more guard members 226 can beintegrally formed with activation housing 210 at its proximal end 212and can extend beyond proximal end 232 of activation shell 230.

Guard members 226 can have a guard member length 226L from proximal end222 toward distal end 224 along the axial direction. The guard memberlength 226L includes a length sufficient so that that when the guardmember 226 comes in contact with a user's body, it can prevent theactivation shell 230 from moving, thus activating the autoinjector 10.In one example, the guard member length 226L can be from about 0.1 inchto about 2 inches or more. For example, guard member length 226L can befrom about 0.2 to about 1 inch, such as from about 0.3 to about 0.9inches, from about 0.3 to about 0.8 inches, from about 0.3 to about 0.5inches, or about 0.4 inches.

Activation of an improperly oriented device without a suitableactivation guard could prevent delivery of the drug within theautoinjector device 10 to the intended region of interest of a user andcould even result in unwanted activation of needle 102 into a user'sthumb. Activation guard 220 and guard members 226 can prevent theactivation shell 230 from contacting a user and moving toward distal end14 to activate an improperly oriented autoinjector device 10. Forexample, when improperly oriented proximal end 12 of autoinjector device10 and activation guard proximal end 222 can abut a user and distal end14 containing a needle can extend away from the user. Activation guard220 is attached to activation housing 210 to prevent linear translationof activation guard 220 with respect to activation housing 210. Applyinga linear force to autoinjector device 10 when activation guard members226 abut a user will therefore not activate autoinjector device 10 toextend needle 102.

Activator unit 200 can include an activation shell 230. Activation shell230 when moved by a user in an axial direction toward distal end 14activates the autoinjector 10. The activation shell 230 can take thegeneral shape of a cylinder, a rectangular prism, a sphere, a cube, acone, a pyramid, or combinations thereof. In another aspect, a crosssection of activation shell 230 can be substantially circular in shape,ovular, round, or any other shape known to one of skill in the art.

Activation shell 230 can be made from a variety of materials. In oneaspect, activation shell 230 can be made from one or more plastics suchas, for example, polyvinylchloride, polytetrafluoroethylene,polyethersulfone, polyethylene, polyurethane, polyetherimide,polycarbonate, polyetheretherketone, polysulfone, polypropulene, cyclicolefin polymer, cyclic olefin copolymer, or combinations thereof.

Activation shell 230 can have an activation shell length 230L. Theactivation shell length 230L can be from about 1 inch to about 10 inchesor more. For example, activation shell length 230L can be from about 1to about 6 inches, such as from about 1 to about 3 inches, from about 2to about 3 inches, or from about 2 to about 2.5 inches. In oneembodiment of the present invention, the activation shell length 230Lcan be shorter than the activation guard length 220L. For example, theactivation shell length 230L can be at least 0.1 inches shorter than theactivation guard length 220L, such as about 0.3 inch, 0.4 inch, 0.5inch, or 1 inch shorter than the activation guard length 220L.

Activation shell 230 can have an activation shell diameter 230D. Theactivation shell diameter 230D is larger than the activation guarddiameter 220D so that it can slide over the activation guard 220. Theactivation shell diameter 230D can be from about 0.1 inch to about 3inches or more. For example, the activation shell diameter 230D can befrom about 0.2 to about 2 inches, such as from about 0.3 to about 1.5inches, from about 0.4 to about 1.2 inches, from about 0.5 to about 1.1inches, from about 0.6 to about 1 inch, from about 0.7 to about 1 inch,or from about 0.8 to about 1 inch.

In one aspect of the invention, activation shell 230 can include adistal groove 242 that can extend radially into at least a portion of aninterior surface of activation shell 230 along circumferential direction50. In one aspect, distal groove 242 can extend into an interior surfaceof activation shell 230 along an entire interior surface of activationshell 230.

Distal groove 242 can have an axial length 245 between the grooveproximal end 243 and the groove distal end 244 to allow for activationof autoinjector device 10. For example, axial length 245 interacts withor engages the radial protrusion 228 to permit translation of activationshell 230 about activation guard 220 and activation housing 210 toactivate autoinjector device 10. In one aspect of the invention, axiallength 245 can be approximately 0.1. In another aspect, axial length 245can range from approximately 0.1 to approximately 0.2 inch.

Activation shell 230 can be prevented from moving toward proximal end 12of autoinjector device 10, for example when proximal end 12 abuts auser, because distal end 244 of distal groove 242 abuts radialprotrusion 228. The positioning of distal end 244 against radialprotrusion 228 only allows activation shell 230 to move toward distalend 14 for activation of autoinjector device 10. This configurationtherefore prevents a user from grasping activation shell 230 to apply alinear force and activate autoinjector device 10 when autoinjectordevice 10 is in an improper orientation, e.g., when proximal end 12abuts a user at the intended injection site.

In an aspect, activation guard 220 can be omitted and axial length 245of distal groove 242 can interact with a radial protrusion on activationhousing 210. For example, shoulder 218 can be omitted and distal groove242 can interact with radial protrusion 216. In this aspect, proximalend 212 of activation housing 210 can extend beyond proximal end 232 ofactivation shell 230.

Distal groove 242 can have a depth from approximately 0.01 toapproximately 0.2 inch.

In another aspect, activation shell 230 can include a proximal grove 240that is configured to couple with a radial protrusion 256 on device lock250 to hold device lock 250 in place on activation shell 230 (FIG. 5 ).Proximal groove 240 can have a groove depth of about 0.01 to about 0.2inch. In another aspect, the groove 240 is an opening and the radialprotrusion 256 is a hook or a clip that can secure the device lock 250to the activation shell. In yet another aspect, the groove 240 is femalethread and the radial protrusion 256 is a male thread. In this aspect,the device lock 250 can be threaded on to the activation shell 230,thereby securing the device lock 250 onto the activation shell 230.

Activation shell 230 can include one or more protrusions 231. Asillustrated in FIG. 3 , protrusions 231 can add texture to the outersurface of activation shell 230 to increase a user's ability to grip andhold activator shell 230. In another aspect, protrusions 231 can providea visual indication as to the end of autoinjector device 10 thatincludes a needle, to assist a user in properly orienting autoinjectordevice 10. As shown in FIGS. 1, 3, and 10-12 , the downward or distaldirection can be visually indicated by the pattern of protrusions 231.For example, protrusions 231 can include a V shape (FIG. 1 ), a U shape(FIGS. 3 and 10 ), a triangle shape (FIG. 11 ), or a curved bar shape(FIG. 12 ). Protrusions 231 can also include a directional texture toprovide a tactile indication as to the end of autoinjector device 10that includes a needle, to assist a user in properly orientingautoinjector device 10 in the dark.

Proximal surface 236 of activation shell 230 can include camouflage toobscure device lock hole 252 and reduce user confusion around needleorientation. In an aspect, proximal surface 236 of activation shell 230can include one or more camouflage structures 238. Camouflage structures238 are structural devices to camouflage and obscure device lock hole252 and reduce user confusion around needle orientation. For example,without camouflage structures 238, proximal end 12 and distal end 14each include a single hole: device lock hole 252 at proximal end 12 anda hole through which needle 102 extends at distal end 14. A user mighttherefore confuse device lock hole 252 with the needle hole, resultingin an improper orientation (e.g. inversion) of autoinjector device 10where proximal end 12 abuts a user at the intended injection site,instead of distal end 14. Camouflage structures 238 obscure device lockhole 252 and prevent a user from thinking device lock hole 252 is theneedle hole. Camouflage structures 238 can be apertures that extendthrough proximal surface 236. In another aspect, camouflage structures238 can be indentations extending distally into proximal surface 236. Inanother aspect, camouflage structures 238 can be protrusions extendingproximally from proximal surface 236. Camouflage structures 238 can takethe shape of a cylinder, a rectangular prism, a sphere, a cube, a cone,a pyramid, or combinations thereof. In another aspect, proximal surface236 can include non-structural camouflage to camouflage and obscuredevice lock hole 252 and reduce user confusion around needleorientation. For example, proximal surface 236 can be colored, forexample, using paint, stickers, or other non-structural features. In anaspect, proximal surface 236 can be colored black to obscure device lockhole 252.

Activator unit 200 can include a device lock 250. Device lock 250 cantake the general shape of a cylinder, a rectangular prism, a sphere, acube, a cone, a pyramid, or combinations thereof. In another aspect, across section of device lock 250 can be substantially circular in shape,ovular, round, or any other shape known to one of skill in the art.

Device lock 250 can be made from a variety of materials. In one aspect,device lock 250 can be made from one or more plastics such as, forexample, polyvinylchloride, polytetrafluoroethylene, polyethersulfone,polyethylene, polyurethane, polyetherimide, polycarbonate,polyetheretherketone, polysulfone, polypropylene, cyclic olefin polymer,cyclic olefin copolymer, or combinations thereof.

Device lock 250 can have a first device lock diameter 250D₁ at itsdistal end. The first device lock diameter 250D₁ can be from about 0.1inch to about 1.5 inches or more. For example, the first device lockdiameter 250D₁ can be from about 0.2 to about 1.4 inches, such as fromabout 0.3 to about 1.3 inches, from about 0.4 to about 1.2 inches, fromabout 0.5 to about 1.1 inches, from about 0.6 to about 1 inch, fromabout 0.7 to about 0.9 inch, or about 0.8 inch. In another embodiment,the first device lock diameter 250D₁ can be smaller than activationshell diameter 230D. For example, the first device lock diameter 250D₁can be at least 0.01 inches smaller than the activation shell diameter230D, such as about 0.05 inch, 0.1 inch, 0.2 inches, or 0.3 inchessmaller than the activation shell diameter 230D.

Device lock 250 can have a second device lock diameter 250D₂ at itsproximal end. The second device lock diameter 250D₂ can include adiameter that is substantially similar to the activation shell diameter230D. For example, the second device lock diameter 250D₂ can be fromabout 0.1 inch to about 3 inches or more. For example, the second devicelock diameter 250D₂ can be from about 0.2 to about 2 inches, such asfrom about 0.3 to about 1.5 inches, from about 0.4 to about 1.4 inches,from about 0.5 to about 1.3 inches, from about 0.6 to about 1.2 inches,from about 0.7 to about 1.1 inches, or from about 0.8 to about 1 inch.In another embodiment, the second device lock diameter 250D₂ can beequal to or larger than activation shell diameter 230D. For example, thesecond device lock diameter 250D₂ can be at least 0.1 inch larger thanthe activation shell diameter 230D, such as about 0.2 inch, 0.3 inch,0.4 inches, or 0.5 inch larger than the activation shell diameter 230D.

Device lock 250 can include a central pin 251 that extends intoactivator unit 200 to prevent the autoinjector 10 from unwantedactivation. Central pin 251 can have a pin length (not shown) sufficientto reach detent projections 202 of the retaining element 206. Centralpin 251 can have a pin length of from about 0.5 inch to about 2 inchesor more. For example, pin length can be from about 0.6 to about 1.5inches, such as from about 0.7 to about 1 inch, or from about 0.8 toabout 0.9 inch inches.

Device lock 250 can include one or more radial protrusions 254positioned along an axial length of device lock 250 to increase the gripand friction between device lock 250 and a user's fingers. Radialprotrusions 254 can make it easier for a user to grip and remove devicelock 250 from autoinjector device 10, especially under low visibilityconditions.

Activator unit 200 can include an activation engine including activationengine housing 201 that can include a pushing mechanism 204 that canpropel piston 208 through film-type seal 107 into pressure pin 105 toforce needle 102 through distal end 14 of autoinjector device 10. Insome embodiments, the needle 102 can puncture the cartridge seal so thatthe needle 102 comes in contact with the cartridge 104 and themedicament in the cartridge 104. In one aspect of the invention, pushingmechanism 204 can be motorized and can include an electric motor, apneumatic motor, or a hydraulic motor coupled to piston 208. In anotheraspect, pushing mechanism 204 can be non-motorized and can include amechanical energy storage device such as a spring or compressed air. Forexample, pushing mechanism 204 can be a compression spring, an extensionspring, a torsion spring, a constant force spring, a variable forcespring, or a coil spring. The spring can include a design to enable thepushing mechanism 204 to exert sufficient force to pierce the skin ofthe user and inject the contents of cartridge 104 into the user. Forexample, the spring can include a design to enable the pushing mechanism204 to assert a pressure of from about 10 psi or less to about 1000 psior more to the content of the cartridge 104. For example, the pushingmechanism 204 asserts a pressure of from about 60 psi to about 500 psi,from about 80 psi to about 350 psi, from about 180 psi to about 330 psi.In one aspect, the pressure is a constant pressure. In another aspect,the initial pressure is greater than the final pressure.

In one aspect of the invention, activation guard 220 can be positionedto at least partially surround the activation housing 210, such that aportion of activation housing 210 can be positioned within an interiorarea of activation guard 220. In a further aspect, activation guard 220can at least partially surround an exterior surface of activationhousing 210. In one aspect of the invention, distal end 224 ofactivation guard can be positioned adjacent to shoulder 218 such thatactivation guard distal surface 225 abuts the surface of shoulder 218.Groove 229 can at least partially surround a radial protrusion 216 thatextends along at least a portion of an outer surface of activationhousing 210 in circumferential direction 50. Radial protrusion 216 canextend circumferentially along an entire outer surface of activationhousing 210. In one aspect, groove 229 and radial protrusion 216 canpermit rotation of activation guard 220 about activation housing 210.This aspect will prevent a user from twisting the activator unit 200 inrelation to the injection unit 100 to separate the two parts anddisassemble the autoinjector 10. Groove 229 and radial protrusion 216can prevent axial translation between activation housing 210 andactivation guard 220.

In one aspect of the invention, activation shell 230 can be positionedat least partially surrounding an activation housing 210, such that aportion of activation housing 210 can be positioned within an interiorarea of activation shell 230. In a further aspect, activation shell 230can at least partially surround an exterior surface of activationhousing 210. Activation shell 230 can be moved towards the distal end ofactivator unit 200 and distal end 14 of autoinjector device 10.

Distal groove 242 can at least partially surround an activation guardradial protrusion 228 that extends along at least a portion of an outersurface of activation guard 220 in circumferential direction 50. Radialprotrusion 228 can extend circumferentially along an entire outersurface of activation guard 220. In one aspect, distal groove 242 andradial protrusion 228 can permit rotation of activation shell 230 aboutactivation guard 220. In an alternate aspect, rotation of activationshell 230 about activation guard 220 can be prevented such thatactivation guard 220 and activation shell 230 rotate together aboutactivation housing 210. As shown in FIG. 13 , for example, rotationbetween activation shell 230 and activation guard 220 can be preventedby the interface of activation shell inward protrusions 233 with guardmembers 226.

Activation guard 220 can extend beyond the proximal end 232 ofactivation shell 230 such that when autoinjector device 10 is improperlyoriented, activation guard 220 can be the first portion of autoinjectordevice 10 that comes into contact with the user. As such, activation ofautoinjector device 10 can be prevented from actuating when improperlyoriented. In an alternate aspect of the invention, the activation guard220 can be integrally formed with activation housing 210 at its proximalend 212 such that guard members 226 can extend beyond proximal end 232of activation shell 230.

Activation guard 220 can include one or more guard members 226 that canextend beyond proximal end 232 of activation shell 230. In anotheraspect, guard members can be integrally formed with activation housing210 at proximal end 212 and can extend beyond proximal end 232 ofactivation shell 230.

Activation guard 220 can be assembled onto activation housing 210 byplacing activation guard distal end 224 over activation housing proximalend 212 and sliding distal end 224 toward activation housing distal end214 until distal surface 225 abuts shoulder 218 and/or groove 229surrounds radial protrusion 216.

After activation guard 220 is assembled onto activation housing 210, theactivation engine including piston 208, retaining element 206, pushingmechanism 204, and detent projections 202 can be placed into activationhousing 210.

Referring now to FIGS. 5-6 , device lock 250 can be maintained inposition on activation shell 230 at activation shell proximal end 232 toprevent the activation shell 230 from moving and activating theautoinjector 10. For example, device lock 250 can include a radialprotrusion 256 that couples with activation shell proximal groove 240 tohold device lock 250 in place on activation shell 230. As shown in FIG.9 , rotation between activation shell 230 and device lock 250 can beprevented by the interface of activation shell inward protrusions 233with device lock tabs 258.

Activation shell 230 can be assembled onto activation guard 220 byplacing activation shell distal end 234 over activation guard proximalend 222 and sliding distal end 234 toward activation guard distal end224 until distal groove 242 surrounds radial protrusion 228. Device lock250 can then be placed over the activation shell proximal end 232 andactivation guard proximal end 222 to secure the activation shell 230 andprevent it from moving axially toward distal end 14 to activate theautoinjector 10.

FIGS. 1 and 7 show activator unit 200 in a storage position. In thisstate, pushing mechanism 204, shown in FIGS. 7-8 as a pretensioned coilspring, can be in a tensioned state between a piston 208 at the distalend and device lock 250 at its proximal end. To maintain the storageposition, retaining element 206 can hold piston 208 in position usingdetent projections 202 that can in turn engage a holding disk 203arranged in the region of proximal end 12 of autoinjector device 10. Theholding disk 203 can be made of a metallic material and can include acoating to improve the strength of the holding disk 203 and, therefore,reduce the probability that the holding disk 203 becomes deformed ordistorted from the force excreted by the pushing mechanism 204. In oneexample, the coating is a metal coating, such as a metal from Group 10through Group 12 of the Periodic Table of Elements. For example, thecoating can be from Group 10 of the Periodic Table of Elements. Anexample of such a coating is a nickel coating. In the storage position,detent projections 202 can be maintained in position against holdingdisk 203 by device lock central pin 251. Device lock central pin 251 canextend into an interior area of detent projections 202. Thus, devicelock central pin 251 can prevent freedom of movement of detentprojections 202, in particular, inward deformation during application ofan axial force to activation shell 230. Device lock central pin 251 canextend through device lock hole 252 in proximal surface 236 ofactivation shell 230. Furthermore, the device lock 250 secures theactivation shell 230 in a position so that it cannot axially move andactivate the autoinjector 10.

When device lock 250 is removed and autoinjector device 10 is orientedproperly, application of force along axial direction 30 toward distalend 14 can cause a relative displacement of the activation shell 230relative to the activation housing 210. Through this displacement,detent projections 202 displace radially inwards, and can release fromholding disk 203. As detent projections 202 release, pushing mechanism204 can apply pressure to piston 208 which can move distally towarddistal end 14 and can puncture film-type seal 107. Piston 208 can thencome into contact with pressure pin 105 which can move distally towarddistal end 14. Pressure pin 105 can press cartridge 104 against needle102, thus connecting cartridge 104 and needle 102.

After cartridge 104 and needle 102 are connected, pressure pin 105,cartridge 104 along with the drug, and needle 102 can move distally bythe pressure applied by pushing mechanism 204. Needle 102 can thenpenetrate into a user's body part.

In one example, the force necessary along axial direction 30 towarddistal end 14 to cause a relative displacement of the activation shell230 can be from about 0.1 lb. to about 40 lbs., such as from about 1 lb.to about 30 lbs., from about 5 lbs. to about 20 lbs. or from about 10lbs. to about 15 lbs.

Should a user improperly orient autoinjector device 10, activation guard220 can abut the user's body part and prevent activation of autoinjectordevice 10. For example, activation guard 220 can prevent an applicationof force along axial direction 30 toward distal end 14 that would causea relative displacement of the activation shell 230 relative to theactivation housing 210. In addition, activation shell 230 can beprevented from moving toward proximal end 12 of autoinjector device 10because distal end 244 of distal groove 242 abuts radial protrusion 228.The positioning of distal end 244 against radial protrusion 228 onlyallows activation shell 230 to move toward distal end 14 for activationof autoinjector device 10.

FIGS. 14 and 15 illustrate additional autoinjector embodiments, withlike numerals corresponding to similar features in FIGS. 1-13 ,described above. As shown in FIG. 14 , autoinjector device 1010 can havea proximal end 12 and a distal end 14. Autoinjector device 1010 caninclude an injection unit 1100 at its distal end 14 and an activatorunit 1200 at its proximal end 12. Activator unit 1200 can include anactivation housing 1210, an activation guard 1226, an activation shell1230, an activation engine within activation housing 1210, and a devicelock 1250. In this aspect, activation guard 1226 can extend acrossproximal end 12. In a further aspect, activation guard 1226 can be fixeddirectly to activation housing 1210. In another aspect, activation guard1226 can be integrally formed with activation housing 1210.

As shown in FIG. 15 , Activator unit 2200 can include an activationhousing 2210, activation guard members 2226, an activation shell 2230,an activation engine within activation housing 2210, and a device lock2250. In this aspect, activation guard members 1226 can include one ormore members that extend from proximal end 12. Activation guard members2226 can extend beyond proximal surface 2232 of activation shell 2230.In a further aspect, activation guard members 2226 can be fixed directlyto activation housing 2210. In another aspect, activation guard members2226 can be integrally formed with activation housing 2210.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections, is intended to be used to interpretthe claims. The Summary and Abstract sections may set forth one or morebut not all exemplary embodiments of the present invention(s) ascontemplated by the inventor(s), and thus, are not intended to limit thepresent invention(s) and the appended claims in any way.

The present invention(s) have been described above with the aid offunctional building blocks illustrating the implementation of specifiedfunctions and relationships thereof. The boundaries of these functionalbuilding blocks have been arbitrarily defined herein for the convenienceof the description. Alternate boundaries can be defined so long as thespecified functions and relationships thereof are appropriatelyperformed.

The foregoing description of the specific embodiments will so fullyreveal the general nature of the invention(s) that others can, byapplying knowledge within the skill of the art, readily modify and/oradapt for various applications such specific embodiments, without undueexperimentation, without departing from the general concept of thepresent invention(s). Therefore, such adaptations and modifications areintended to be within the meaning and range of equivalents of thedisclosed embodiments, based on the teaching and guidance presentedherein. It is to be understood that the phraseology or terminologyherein is for the purpose of description and not of limitation, suchthat the terminology or phraseology of the present specification is tobe interpreted by the skilled artisan in light of the teachings andguidance.

The breadth and scope of the present invention(s) should not be limitedby any of the above-described exemplary embodiments, but should bedefined only in accordance with the following claims and theirequivalents.

1.-14. (canceled)
 15. An activator unit for an autoinjector, theactivator unit comprising: an activation housing having an activationengine; an activation guard configured about an exterior surface of theactivation housing, the activation guard extending beyond a proximal endof the activation housing; and an activation shell configured about atleast a portion of an exterior surface of the activation guard and theactivation guard extending beyond a proximal end of the activationshell.
 16. The activator unit of claim 15, wherein the activationhousing includes at least one protrusion, and wherein the activationguard includes a groove surrounding the at least one activation housingprotrusion such that the activation guard is configured to rotate aboutthe activation housing.
 17. The activator unit of claim 16, wherein theactivation guard includes at least one protrusion, and wherein theactivation shell includes at least one groove surrounding the at leastone activation guard protrusion such that the activation shell isconfigured to translate about the activation guard.
 18. The activatorunit of claim 15, wherein a proximal surface of the activation shellincludes a camouflage structure to camouflage a device lock protrusionopening.
 19. The activator unit of claim 15, wherein a distal surface ofthe activation guard abuts a shoulder of the activation housing.
 20. Theactivator unit of claim 15, wherein the activation shell and activationguard are configured such that relative axial rotation between them isprevented.
 21. The activator unit of claim 15, wherein the activationshell and activation guard are configured such that they rotatetogether.
 22. An activation guard for an autoinjection device to preventa user from activating the autoinjection device in an incorrectdirection, the activation guard comprising: a guard member to extendproximally beyond an activation housing and an activation shell; agroove configured on a portion of the guard member to engage anactivation housing projection; and a projection configured on a portionof the guard member to engage an activation shell groove.
 23. Theactivation guard of claim 22, wherein a portion of the activationhousing is positioned within an interior area of the activation guard,and wherein a portion of the activation guard is positioned within aninterior area of the activation shell.
 24. The activation guard of claim22, wherein the guard member abuts a user in the incorrect direction,and wherein an injection unit abuts a user in a correct direction.25.-37. (canceled)